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This is an open label phase I study, to assess the safety of a novel malaria vaccine, AdCh63 CS, simian adenovirus encoding Plasmodium falciparum liver stage antigen, Circumsporozoite protein. All volunteers recruited will be healthy adults. They will be primed with various doses of AdCh63 CS administered intramuscularly. Some of the volunteers will receive a booster vaccination with MVA CS administered via intramuscular route. Safety data will be collected for each vaccination regimen. Secondary aim of this study will be to assess the immune responses generated by vaccination.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1A | Experimental | AdCh63 CS 5x10^9 vp |
|
| Group 1B | Experimental | ChAd63 CS 5x10^9 vp Day 0; MVA CS 2x10^8 pfu Day 56 |
|
| Group 2A | Experimental | AdCh63 CS 5 x 10^10 vp |
|
| Group 2B | Experimental | ChAd63 CS 5x10^10 vp Day 0; MVA CS 2x10^8 pfu Day 56 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ChAd63 CS | Biological | ChAd63 CS 5x10^9 vp intra-muscularly Day 0 |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Safety assessment of new candidate malaria vaccines ChAd63 CS | To assess the safety of new candidate malaria vaccines ChAd63 CS administered alone and with MVA CS in a prime-boost regime to healthy volunteers by recording local and systemic solicited and unsolicited adverse events. | Participants will be followed for the duration of the study, an expected average of 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Assessment of immune response induced by vaccination | To assess the humoral and cellular immune responses generated by ChAd63 CS when administered to healthy volunteers alone and with MVA CS by assessing induced antibody and T cell response to the vaccine insert. | Participants will be followed for the duration of the study, an expected average of 12 months |
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Inclusion Criteria
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sam McConkey | Clinical Research Centre Royal College of Surgeons in Ireland (RCSI) | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinical Research Centre Royal College of Surgeons in Ireland (RCSI), Beaumont Hospital | Dublin | Ireland |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25522180 | Derived | de Barra E, Hodgson SH, Ewer KJ, Bliss CM, Hennigan K, Collins A, Berrie E, Lawrie AM, Gilbert SC, Nicosia A, McConkey SJ, Hill AV. A phase Ia study to assess the safety and immunogenicity of new malaria vaccine candidates ChAd63 CS administered alone and with MVA CS. PLoS One. 2014 Dec 18;9(12):e115161. doi: 10.1371/journal.pone.0115161. eCollection 2014. |
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| ID | Term |
|---|---|
| D008288 | Malaria |
| ID | Term |
|---|---|
| D011528 | Protozoan Infections |
| D010272 | Parasitic Diseases |
| D007239 | Infections |
| D000096724 | Mosquito-Borne Diseases |
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| ChAd63 CS, MVA CS |
| Biological |
ChAd63 CS 5x10^9 vp intra-muscularly Day 0; MVA CS 2x10^8 pfu intra-muscularly Day 56 |
|
| ChAd63 CS | Biological | ChAd63 CS 5x10^10 vp intra-muscularly Day 0 |
|
| ChAd63, MVA CS | Biological | ChAd63 CS 5x10^10 vp intra-muscularly Day 0; MVA CS 2x10^8 pfu intra-muscularly Day 56 |
|
| D000079426 |
| Vector Borne Diseases |